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Biotech / Medical : Ionis Pharmaceuticals (IONS)

IONS 73.29

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To: marc ultra who wrote (2048)	6/26/1998 8:06:00 AM
From: TomOrt	Read Replies (1) of 4676

biz.yahoo.com Friday June 26, 6:01 am Eastern Time Company Press Release SOURCE: CIBA Vision ISIS and CIBA Vision's Drug For CMV Retinitis is Scheduled for FDA Advisory Committee Review NDA Receives Priority Review from the FDA ATLANTA and CARLSBAD, Calif., June 26 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) and CIBA Vision Corporation, the eye care unit of world life sciences leader, Novartis AG, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for fomivirsen under the agency's priority review process and has scheduled a date for a public advisory committee meeting. The trade name for fomivirsen is Vitravene(TM). The priority review process is reserved for therapies that may substantially improve the standard of treatment for a certain disease or condition. Isis filed the NDA for Vitravene on April 9, 1998. In conjunction with receiving priority status review, the FDA will convene The Ophthalmic Drugs subcommittee of the Dermatologic and Ophthalmic Drugs Advisory Committee on July 22, 1998 to review the data contained in the NDA and issue its recommendations. Vitravene is a treatment for cytomegalovirus (CMV) retinitis, an opportunistic infection in AIDS patients that results in blindness. Vitravene represents the world's first compound based on antisense technology to be filed for commercial marketing review. Results from Phase III trials of Vitravene demonstrated that patients with CMV retinitis experienced a delay in the time to disease progression. This press release contains forward-looking statements........

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